The National Agency for Food and Drugs Administration and Control (NAFDAC) has recalled Benylin Paediatrics Syrup manufactured by Johnson & Johnson, following recent toxicity findings in the laboratory on the product.
Benylin Paediatric syrup is indicated for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions in children aged 2 to 12 years.
The agency in a statement on Wednesday, disclosed that Laboratory analysis conducted on the product showed that it contains an unacceptable high level of diethylene glycol and was found to cause acute oral toxicity in laboratory animals.
It further stated that diethylene glycol is toxic to humans when consumed and can prove fatal. “Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death”.
The product, with the following information: batch no “329304”, manufacturing date: 2021, and imported by Johnson and Johnson company West Africa, is also be expiring in April 2024.
NAFDAC management said it has directed Johnson and Johnson company West Africa to initiate the recall of the batch, while the notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
The regulatory agency therefore urged all importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard (contaminated) regulated products.
It further warned that all medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
“Anyone in possession of the above-mentioned product is advised to immediately discontinue sale or use and submit stock to the nearest NAFDAC office. If you witness any adverse reaction/event after the use of this product in any children, you are advised to direct such patients for immediate medical attention from a qualified healthcare professional.
“Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC”, the agency emphasised.
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